Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinling Hospital, China
About this trial
The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
Subjects must be >/= 18 years of age at time of informed consent.
Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection.
Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
Disqualifiers
Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane.
Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
Trial design
Design model
Single group
Treatments tested in this trial
Surgery
Procedure/SurgeryTumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
Camrelizumab
DrugCamrelizumab will be administered 6 weeks post-tumor resection.
SJ-Neo006
Biological/VaccineSJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
Gemcitabine+Abraxane
DrugGemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Pancreatic CancerExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Incidence of Treatment Emergent Adverse Events (TEAEs)
To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame
2 yearsSecondary outcomes
1
Disease control rate (DCR)
The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time.
Time frame
3,6,12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jinling Hospital, China
Lead sponsor
Jiangsu Synthgene Biotechnology Co.Ltd.
Collaborator
Source ClinicalTrials.gov